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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. RESOLUTE ONYX¿ CORONARY DRUG-ELUTING STENT

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MEDTRONIC, INC. RESOLUTE ONYX¿ CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number RONYX35038UX
Device Problems Material Rupture (1546); Activation, Positioning or Separation Problem (2906)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Event Date 11/13/2019
Event Type  malfunction  
Event Description
While attempting to deploy a coronary stent in to the right coronary artery, balloon ruptured inside stent before it was opened. Patient became hypotensive and bradycardic requiring iv fluids and atropine.
 
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Brand NameRESOLUTE ONYX¿
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC, INC.
710 medtronic pkwy
minneapolis MN 55432
MDR Report Key9543892
MDR Text Key173501584
Report Number9543892
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier00643169557130
UDI-Public(01)00643169557130
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRONYX35038UX
Device Lot Number0009926856
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/18/2019
Event Location Hospital
Date Report to Manufacturer01/03/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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